New analysis of CVD-REAL study of SGLT-2 inhibitors (SGLT-2i), including Farxiga shows lower all cause death risk reduction.- AstraZeneca

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AstraZeneca announced results from a new analysis of its landmark CVD-REAL study, the first large real-world evidence study of its kind evaluating the risk of all-cause death (ACD), hospitalisation for heart failure (hHF), heart attack (myocardial infarction or MI) and stroke in patients with type-2 diabetes (T2D) receiving treatment with SGLT-2 inhibitors (SGLT-2i), including Farxiga (dapagliflozin) versus other glucose-lowering medicines. The results were presented as a late breaker at the American College of Cardiology’s 67th Annual Scientific Session and published in the Journal of the American College of Cardiology.

The new analysis (CVD-REAL 2) assessed data from more than 400,000 patients across six countries (Australia, Canada, Israel, Japan, Singapore and South Korea), 74% of whom did not have a history of established cardiovascular (CV) disease. Results showed that across this broad population of patients with T2D, treatment with an SGLT-2i (Farxiga, empagliflozin, ipragliflozin, canagliflozin, tofogliflozin or luseogliflozin) was associated with a 49% lower risk of ACD, 36% of hHF, 19% of MI and 32% of stroke (p?0.001 for all) compared to other T2D medicines. There was also a 40% lower risk of the composite endpoint of hHF or ACD (p<0.001).

The DECLARE trial (anticipated to read out in the second half of 2018) will answer the important CV efficacy and safety questions about Farxiga. DECLARE is the broadest and most representative CV outcomes trial in the SGLT-2i class, and the only one with the clinically-relevant composite of hHF/CV death as a co-primary endpoint.

About CVD-REAL : The CVD-REAL 2 results are consistent with the primary results from CVD-REAL. Of the patients in CVD-REAL 2, some 75% were on Farxiga, 9% on empagliflozin, 8% on ipragliflozin (only available in South Korea and Japan), 4% on canagliflozin, 3% on tofogliflozin and 1% on luseogliflozin (both only available in Japan). The CVD-REAL study is ongoing and future analyses will be conducted. The data for the study were obtained from anonymised real-world sources including medical records, claims databases and national registries, and were not independently adjudicated or verified against source documents. The meta-analyses were validated by the independent academic statistical group at St. Luke’s Mid America Heart Institute, Kansas City, US. While CVD-REAL was a large study with a robust propensity-matching technique, given its observational nature the possibility of residual, unmeasured confounding factors cannot be definitively excluded.

See- Kosiborod, M. "Lower Risk of Cardiovascular Events and Death Associated with Initiation of SGLT-2 Inhibitors versus Other Glucose Lowering Drugs" - Real World Data Across Three Major World Regions with More Than 400,000 Patients: The CVD-REAL 2 Study. Presented at the American College of Cardiology 67th Annual Scientific Session, 2018.

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